Question:

Where can I buy the 13485:2012 standard?

- Michelle Baudo, Quality Manager, Curbell

Answer:

There are a number of online stores where you can purchase this standard. I have included a couple of the more popular sites for you at the end of the answer, but they are not the only options. However, before purchasing the standard it is important to understand the different versions of the ISO 13485 standard that are currently “out there”.

ISO 13485:2003 is the primary version of ISO that is currently in effect worldwide today, with the exceptions of the modifications noted below. This is the international version of the standard used around the world, and it is scheduled for revision in 2015.

EN ISO 13485:2012 recently became the latest European harmonized version of ISO 13485 (thus the “EN” in the title). This 2012 European variant replaced the prior European harmonized version (EN ISO 13485:2003) which is now considered obsolete. EN ISO 13485:2012 is applicable only to manufacturers placing devices on the market in Europe, and is applied when a manufacturer elects to employ ISO 13485 as a harmonized solution to meet the quality system requirements of European directives such as the European Medical Device Directive (93/42/EEC).

For the rest of the world, ISO 13485:2003 (no “EN” designator) remains the applicable standard.

It is important to note that the only differences between EN ISO 13485:2012 compared with the 2003 version are with respect to the foreword and Annex Z’s. There have been no changes to the normative content; in other words, the requirements clauses of the standard remain unchanged.